Main Focus of the StudyNCT05116033
Value of Platelet Indices as Predictive Factor in Thrombocytopenia
An observational study of Main Focus of the Study, run by Assiut University.
Trial summary
Platelets are essential blood component involved in primary hemostasis. A platelet count of less than 150 × 109/L is considered to be thrombocytopenia The causes of thrombocytopenia can be divided into two major groups, a decreased production of platelets or an under proliferative BM and an over-destruction of… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Main Focus of the Study
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2021to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Adult, Older adult
Study population: Participants of the study will be confirmed as thrombocytopenic patients.
Who may be able to join
- Age more than 18 years old regardless of gender.
- Platelet count below 100000/cu mm.
- Confirmed diagnosis aplastic anaemia.
- Confirmed diagnosis immune thrombocytopenia
Who cannot join
- Patient who received a platelet or blood transfusion within two weeks prior MPV analysis.
- Splenectomized patients
- Patients with chronic infection or inflammations.
- Diabetics and patients with coronary artery disease.
- Patients on anti- platelet or anti-inflammatory drugs.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Value of the Platelet Indices as a Predictive Factor in Adult Thrombocytopenic Patients
Platelets are essential blood component involved in primary hemostasis. A platelet count of less than 150 × 109/L is considered to be thrombocytopenia The causes of thrombocytopenia can be divided into two major groups, a decreased production of platelets or an under proliferative BM and an over-destruction of platelets. Under proliferative BM defects most common cause is aplastic anemia, On the contrary, peripheral destruction of platelets may be as a result of an immune-mediated process namely immune thrombocytopenia (ITP)
Read the detailed description
ITP is a common auto-immune disease in which platelet count is reduced in peripheral blood leading to petechiae and hemorrhage. The platelet count is decreased because there are auto-antibodies in circulation against platelets that bind to platelets surface and destroy them in the spleen . Aplastic anemia is characterized by suppression of bone marrow function resulting in progressive pancytopenia. The hematology analyzers can now give us certain parameters that can give information about platelets. These parameters are referred to as platelet indices in literature. Platelet indices include mean platelet volume (MPV), platelet distribution width (PDW) and platelet large cell ratio (P-LCR) . They are sensitive, non-invasive, inexpensive biomarkers. MPV is the most commonly investigated platelet parameter, signifies the average size of platelets in the blood. PDW is a marker of platelet anisocytosis, which describes distribution of platelets produced by megakaryocytes and increases upon platelet activation. P-LCR is another marker of platelet activity, is a percentage of all platelets with a volume measuring over 12 fl circulating in the bloodstream .
- Conditions
- Main Focus of the Study
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the prognostic predictive value of the platelet indices in thrombocytopenic patients.
- Exploring the validity of platelets indices as prognostic biomarkers in thrombocytopenic patients.
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start20 Dec 2021 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Main Focus of the StudyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahy nour Z Abed elhi,MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116033
- Sponsor's protocol ID
- VOTIAAFITP
- Status last verified
- Nov 2021
- First submitted
- 15 Sep 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Negash M, Tsegaye A, G/Medhin A. Diagnostic predictive value of platelet indices for discriminating hypo productive versus immune thrombocytopenia purpura in patients attending a tertiary care teaching hospital in Addis Ababa, Ethiopia. BMC Hematol. 2016 Jul 1;16:18. doi: 10.1186/s12878-016-0057-5. eCollection 2016.
PubMed 27375850Norrasethada L, Khumpoo W, Rattarittamrong E, Rattanathammethee T, Chai-Adisaksopha C, Tantiworawit A. The use of mean platelet volume for distinguishing the causes of thrombocytopenia in adult patients. Hematol Rep. 2019 Mar 29;11(1):7732. doi: 10.4081/hr.2019.7732. eCollection 2019 Feb 19.
PubMed 30996849Khan MI, Ullah I. Diagnostic importance of mean platelet volume, platelet distribution width and platelet large cell ratio as screening tool in immune thrombocytopenia. Porto Biomed J. 2020 Nov 24;5(6):e094. doi: 10.1097/j.pbj.0000000000000094. eCollection 2020 Nov-Dec.
PubMed 33283064Pogorzelska K, Kretowska A, Krawczuk-Rybak M, Sawicka-Zukowska M. Characteristics of platelet indices and their prognostic significance in selected medical condition - a systematic review. Adv Med Sci. 2020 Sep;65(2):310-315. doi: 10.1016/j.advms.2020.05.002. Epub 2020 Jun 4.
PubMed 32505856
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of the Platelet Indices as a Predictive Factor in Adult Thrombocytopenic Patients
- ClinicalTrials.gov ID
- NCT05116033
- Acronym / sponsor ID
- VOTIAAFITP
- Conditions
- Main Focus of the Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Dec 2021 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Platelets are essential blood component involved in primary hemostasis. A platelet count of less than 150 × 109/L is considered to be thrombocytopenia The causes of thrombocytopenia can be divided into two major groups, a decreased production of platelets or an under proliferative BM and an over-destruction of platelets. Under proliferative BM defects most common cause is aplastic anemia, On the contrary, peripheral destruction of platelets may be as a result of an immune-mediated process namely immune thrombocytopenia (ITP)
Detailed description
ITP is a common auto-immune disease in which platelet count is reduced in peripheral blood leading to petechiae and hemorrhage. The platelet count is decreased because there are auto-antibodies in circulation against platelets that bind to platelets surface and destroy them in the spleen . Aplastic anemia is characterized by suppression of bone marrow function resulting in progressive pancytopenia. The hematology analyzers can now give us certain parameters that can give information about platelets. These parameters are referred to as platelet indices in literature. Platelet indices include mean platelet volume (MPV), platelet distribution width (PDW) and platelet large cell ratio (P-LCR) . They are sensitive, non-invasive, inexpensive biomarkers. MPV is the most commonly investigated platelet parameter, signifies the average size of platelets in the blood. PDW is a marker of platelet anisocytosis, which describes distribution of platelets produced by megakaryocytes and increases upon platelet activation. P-LCR is another marker of platelet activity, is a percentage of all platelets with a volume measuring over 12 fl circulating in the bloodstream .
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants of the study will be confirmed as thrombocytopenic patients.
Key inclusion criteria (4 listed)
- Age more than 18 years old regardless of gender.
- Platelet count below 100000/cu mm.
- Confirmed diagnosis aplastic anaemia.
- Confirmed diagnosis immune thrombocytopenia
Key exclusion criteria (5 listed)
- Patient who received a platelet or blood transfusion within two weeks prior MPV analysis.
- Splenectomized patients
- Patients with chronic infection or inflammations.
- Diabetics and patients with coronary artery disease.
- Patients on anti- platelet or anti-inflammatory drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the prognostic predictive value of the platelet indices in thrombocytopenic patients.
Time frame: 6months
• Exploring the validity of platelets indices as prognostic biomarkers in thrombocytopenic patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Results publication: PubMed 27375850Negash M, Tsegaye A, G/Medhin A. Diagnostic predictive value of platelet indices for discriminating hypo productive versus immune thrombocytopenia purpura in patients attending a tertiary care teaching hospital in Addis Ababa, Ethiopia. BMC Hematol. 2016 Jul 1;16:18. doi: 10.1186/s12878-016-0057-5. eCollection 2016.
- Results publication: PubMed 30996849Norrasethada L, Khumpoo W, Rattarittamrong E, Rattanathammethee T, Chai-Adisaksopha C, Tantiworawit A. The use of mean platelet volume for distinguishing the causes of thrombocytopenia in adult patients. Hematol Rep. 2019 Mar 29;11(1):7732. doi: 10.4081/hr.2019.7732. eCollection 2019 Feb 19.
- Results publication: PubMed 33283064Khan MI, Ullah I. Diagnostic importance of mean platelet volume, platelet distribution width and platelet large cell ratio as screening tool in immune thrombocytopenia. Porto Biomed J. 2020 Nov 24;5(6):e094. doi: 10.1097/j.pbj.0000000000000094. eCollection 2020 Nov-Dec.
- Results publication: PubMed 32505856Pogorzelska K, Kretowska A, Krawczuk-Rybak M, Sawicka-Zukowska M. Characteristics of platelet indices and their prognostic significance in selected medical condition - a systematic review. Adv Med Sci. 2020 Sep;65(2):310-315. doi: 10.1016/j.advms.2020.05.002. Epub 2020 Jun 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Main Focus of the Study, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalia G mahran, prof.dr (01007120821, daliagm2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the prognostic predictive value of the platelet indices in thrombocytopenic patients. (time frame: 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05116033, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.